Myovant’s Relugolix Won’t Be Stopped By Missed Endpoint
Approval Still Expected And Differentiation Remains Intact
The miss on improving castration resistance-free survival in Phase III trial is not likely to affect the ongoing FDA review, the company and analysts agree.
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Japanese firm’s recent decision to halt development of its lead oncology asset, gained through a multi-billion-dollar acquisition where it was the main attraction, not only has a financial cost but may prompt more strategic deal-making.
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
The first Phase III trial testing relugolix combination therapy in endometriosis pain showed efficacy with minimal bone mineral density loss, an issue with AbbVie's rival drug Orilissa. An US NDA was also filed in prostate cancer.